Label: MAXIMUM STRENGTH ORIGINAL DIAPER RASH- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 30, 2013

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  • Active ingredient

    Zinc Oxide........40.0%

  • Purpose

    Skin Protectant

  • Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps seal out wetness
  • Warnings

    For external use only.

  • When using this product

    • do not get into eyes
  • Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
  • Keep Out of Reach of Children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • change wet and soiled diapers promptly
    • cleanse the diaper area
    • allow to dry
    • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged
  • Other Information

    • store at 20º to 25ºC (68º to 77ºF)
  • Inactive ingredients

    cod liver oil, talc, petrolatum, lanolin, water, methylparaben, fragrance, BHA

  • Package/Label Principal Display Panel

    Cottontails baby care

    maximum strength original diaper rash paste

    Take care of your little one, from the top of their head to their tiny little toes, with Cottontails®.

    40% zinc oxide

    Helps to heal, soothe & prevent diaper rash

    Compare to Desitin® Maximum Strength Original Paste ingredients

    NET WT. 4 OZ. (113 g)

    Designed to be gentle on your little one, our skin care products will keep their skin smooth, soft and ready for the next exciting day.

    Maximum Strength Original Diaper Rash Paste provides overnight relief for your baby's delicate skin. This rich, dermatologist-tested and hypoallergenic formula contains the maximum level of zinc oxide to instantly form a protective barrier to help heal and soothe irritation caused by diaper rash.

    *This product is not manufactured or distributed by Johnson & Johnson® Consumer Products Company, owner of the registered trademark Desitin®

    DISTRIBUTED BY FOODHOLD U.S.A., LLC
    LANDOVER, MD 20785
    1-877-846-9949
    © 2013 Ahold Licensing, Sarl
    MADE IN ISRAEL
    Quality guaranteed or your money back.
    0D927 D4 C1

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH ORIGINAL DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-927
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE400 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    COD LIVER OIL (UNII: BBL281NWFG)  
    TALC (UNII: 7SEV7J4R1U)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LANOLIN (UNII: 7EV65EAW6H)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-927-111 in 1 CARTON
    1113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/15/2013
    Labeler - American Sales Company (809183973)
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